- University of Colorado (Aurora, CO)
- …**Description** **University of Colorado Anschutz Medical Campus** **Department: Colorado Multiple Institutional Review Board - Office of Regulatory ... a year for year basis. **Preferred Qualifications:** + Experience working with Institutional Review Boards or OHRP/FDA regulations regarding human subject… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop...responsibilities as assigned CRC-A + Prepare and process all Institutional Review Board ( IRB… more
- Cedars-Sinai (Beverly Hills, CA)
- …federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board ( IRB ). **Primary Duties and ... the department. Scheduling will be determined by the hiring manager based on operational priorities. At this time, we...closely with a regulatory coordinator or directly with the Institutional Review Board ( IRB… more
- Stanford University (Stanford, CA)
- …compliance with all applicable institutional , regulatory, and federal requirements. Monitor Institutional Review Board ( IRB ) submissions and ... Clinical Research Lab Manager (Fixed-term 2 years) **School of Medicine, Stanford,...or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and… more
- University of Miami (Miami, FL)
- …a proven experience in managing regulatory documentation and submissions to entities such as the Institutional Review Board ( IRB ) and the Food and Drug ... SOPs and templates with guidance from the PI/Clinical Research Manager . + Oversees and facilitates eligibility screening and study...initial study requests, annual reviews and modifications to the Institutional Review Board ( IRB… more
- Dana-Farber Cancer Institute (Boston, MA)
- …identify priority trials and complete submissions through IRIS. Process protocols through DFCI Institutional Review Board (and other institutions' IRBs) + ... Application (NPA) vetting and prioritization, ensuring that IRIS submission, review and approval timelines / institutional benchmarks...continuing reviews, events, and other submissions for SRC and IRB review and approval + Support the… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …and monitors practices to ensure regulatory documentation involving clinical trials complies with Institutional Review Board ( IRB ) policies and ... maintain all correspondence and regulatory documentation required by the IRB , FDA, IND Sponsors, and other institutional ...+ Process IND safety reports, maintain documentation of PI review and submit safety reports to the IRB… more
- Stanford University (Stanford, CA)
- …bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. IRB submissions. + 2-4 years ... regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to… more
- Dialysis Clinic, Inc. (Albany, GA)
- …and post-study closure. They prepare documentation for submission for review by the Institutional Review Board ( IRB ), recruit and screen study ... including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board ( IRB ) applications, CV's,… more
- Houston Methodist (Houston, TX)
- …laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board ( IRB ), Food and Drug ... and performing study specific regulatory processes such as local IRB submissions in compliance with Good Clinical Practices (GCP)...study personnel. + Acts as a liaison between the institutional review committees, regulatory agencies, and the… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... compliance is essential. This position requires adherence to University of Pennsylvania, IRB , and FDA guidelines, and may occasionally involve off-site work or… more
- University of Pennsylvania (Philadelphia, PA)
- …study initiation; maintaining study regulatory binders; submission of all regulatory paperwork to our institutional review board ( IRB ) and any applicable ... and resources, and much more. Posted Job Title Cardiac Surgery Program Manager (Department of Surgery) Job Profile Title Clinical Research Program Manager… more
- New York University (New York, NY)
- …NYCPS, CUNY, community-based organizations) + Ensure compliance with data use agreements and institutional review board ( IRB ) requirements and adherence ... center housed at New York University, invites applications for a full-time Data Manager . We conduct rigorous research to inform education policy and practice in New… more
- SUNY Upstate Medical University (Syracuse, NY)
- …Principal Investigator with regulatory compliance including Institutional Biosafety Committee (IBC), Institutional Review Board ( IRB ), and ... Job Summary: We are seeking a dynamic Lab Manager to join our dengue virus immunology research...Care and Use Committee (IACUC) protocols. Additionally, the Lab Manager will have the opportunity to pursue their own… more
- Johns Hopkins University (Baltimore, MD)
- …and make recommendations on operational issues. + Assist with preparation of submissions to the Institutional Review Board ( IRB ) + Liaison with IRB ... Candidate will report to the Coordinating Center Clinical Research Manager and work closely with the Principal Investigators. **Specific...case report forms (ie REDCap) and study calendars + Review study documents, prepare for JHM IRB … more
- University of Miami (Miami, FL)
- …FUNCTIONS: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board ( IRB ) from study activation to ... faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The University of… more
- CommonSpirit Health (Santa Maria, CA)
- …study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board ( IRB ) application form(s), ... with the CommonSpirit Health Research Institute Market Clinical Research Manager (MCRM), Principal Investigators, co- and sub-investigators, clinical and ancillary… more
- Mount Sinai Health System (New York, NY)
- …assistance and guidance in the preparation of budgets, Grants and Contracts Office/ Institutional Review Board paperwork, application forms, no-cost ... and contracts applications are directed and submitted to appropriate committees (ie, IRB ; Financial Conflict of Interest in Research Committee) for review .… more
- University of Utah (Salt Lake City, UT)
- …documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports. ... documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.… more
- CUNY (New York, NY)
- …and exempt review decisions. + Manages and develops IRB review processes, including protocol distribution for full board and expedited reviews, and ... Research Programs Manager (Compliance and Human Research Protections) - Office...including the Human Subjects Research Program (HSRP), Export Controls, IRB agreements, approvals, amendments, and Intellectual Property (as applicable).… more